Overview of OMS Change Request Process (updated)

16 August 2018
EMA/440168/2018
Information Management Division

This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of the SPOR programme and for all stakeholders who are using OMS
data services. The information here applies to both human and veterinary stakeholders; however, there may be different impacts experienced by industry stakeholders and regulatory bodies (mainly NCAs).

OMS data services opened to stakeholders in December 2017. They were invited to start registering their SPOR users and to begin requesting changes and additions to the organisation data content. Since the launch, the uptake of OMS has been very good, with over a thousand change requests submitted in the first six months. OMS change requests are one of the key aspects of the service. They enable the creation of a new organisation, the addition of a location or updating of an existing organisation and/or locaton data. The process itself is simple and consists of three steps: submission, validation and approval.

OMS Operating Model (updated)

This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of the SPOR programme and for all stakeholders who will be using RMS data management services. The information applies to both human and veterinary stakeholders; however, there may be different impacts experienced by NCAs and industry stakeholders.

In the OMS operating model, the stakeholders, new process and functional capabilities are the key components to ensure delivery of the service. This document describes the range of services available for stakeholders to use, the process to register organisation data or request data updates. It also outlines stakeholder interactions and identifies roles. The high-level concept of the OMS Operating Model is shown in Figure 1 below.